Clinical Trials in Medical Retina

From EyeWiki
Assigned editor:
"Error: Invalid time." contains an extrinsic dash or other characters that are invalid for a date interpretation.
Review:
Assigned status Update Pending
.


Protocol W 2021

Maturi RK, Glassman AR, Josic K, Antoszyk AN, Blodi BA, Jampol LM, Marcus DM, Martin DF, Melia M, Salehi-Had H, Stockdale CR, Punjabi OS, Sun JK; DRCR Retina Network. Effect of Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial. JAMA Ophthalmol. 2021 Jul 1;139(7):701-712. doi: 10.1001/jamaophthalmol.2021.0606. PMID: 33784735; PMCID: PMC8010644.

Objectives

The goal was to determine the efficacy of intravitreous aflibercept injections compared to sham in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR. The role of anti-VEGF in managing NPDR without center-involved diabetic macular edema (CI-DME) has not been established.

Design

Clinical trial, eyes with moderate to severe NPDR without CI-DME were randomized to receive 2.0 mg aflibercept or sham. Treatment was given at baseline; 1, 2, and 4 months; and every 4 months through 2 years. Between 2 and 4 years, treatment was deferred if the eye had mild NPDR or better. Aflibercept was administered in both groups if CI-DME with vision loss (≥10 letters at 1 visit or 5-9 letters at 2 consecutive visits) or high-risk proliferative diabetic retinopathy (PDR) developed.

Main outcomes measures

Development of CI-DME with vision loss or PDR.

Results

From 2016 to 2020, 328 participants (399 eyes) with moderate to severe NPDR without CI-DME were randomized to aflibercept injections (n = 200) or sham (n = 199). The 2-year cumulative probability of developing CI-DME with vision loss or PDR was 16.3% with aflibercept vs. 43.5% with sham. The 2-year cumulative probability of developing PDR was 13.5% in the aflibercept group vs. 33.2% in the sham, and the 2-year cumulative probability of developing CI-DME with vision loss was 4.1% in the aflibercept group vs. 14.8% in the sham group. The mean (SD) change in VA from baseline to 2 years was not significant, -0.9 (5.8) letters with aflibercept and -2.0 (6.1) letters with sham.

Limitations

20% loss of follow-up.

Conclusions

Eyes with moderate to severe NPDR treatment with periodic aflibercept decreased the development of PDR or vision-reducing CI-DME. However, through 2 years, preventive aflibercept did not confer VA benefit compared with observation plus treatment with aflibercept only after development of PDR or vision-reducing CI-DME.

Pearls for clinical practice

Eyes with moderate to severe NPDR can be observed and treated if required.

The Academy uses cookies to analyze performance and provide relevant personalized content to users of our website.